This document summarizes early outcomes from the US IDE trial and global ENGAGE registry of the Endurant AAA endograft. In the US trial (n=150), the 30-day major adverse event rate was 4.0% and there was no mortality. At 1 year, the aneurysm sac size decreased or remained stable in most patients and the reintervention rate was low. The ENGAGE registry includes over 800 patients so far who mirror "real-world" cases. Procedural success was high at 99.6% with a median implant time of 90 minutes. Early outcomes suggest the Endurant endograft is a safe and effective option for treating abdominal aortic aneurysms.

1. 37th Annual VEITH Symposium 2010 Contemporary One year EVAR Outcomes from the US IDE trial and ENGAGE Global Registry of the Endurant AAA Endograft Device Michel S. Makaroun MD Division of Vascular Surgery University of Pittsburgh for the US Endurant Pivotal Trial Investigators

2. The Bifurcated Endurant EndoGraft Description Modular Stent-Graft Multi-filament Polyester Fabric Electropolished Nitinol Stent Active Suprarenal fixation 3 cm Overlap Zone Pt-Ir and Gold Markers Endurant

4. Limb stent geometry designed for flexibility

7. Endurant Delivery System Allows for Slow Deliberate and Accurate Proximal Deployment

8. The Endurant EndoGraft

10. 26 sites: Both Academic and Community Hospitals

11. 150 patients

12. April 2008 to May 2009

13. One year follow-up visits completed

14. All Imaging reviewed by a Core Lab (M2S)

16. Neck length ≥ 10 mm

17. Neck angulation ≤ 60 degrees

18. Iliac Fixation length ≥ 15 mm

21. The Endurant US Regulatory Study Demographics

22. The Endurant US Regulatory Study Procedure One AAA ruptured during the procedure which was still completed successfully

25. The Endurant US Regulatory Study Long Narrow Neck Rx: Fem-Fem Distal Neck 15mm Right EIA 4 mm CT on Day 20 Compressed and Occluded R Limb

28. Six Deaths during first year. None AAA related (CEC)Primary Cause of Death Days from Implant Stroke 90 COPD 128 Pulmonary fibrosis 215 Lung cancer 267 Multiple organ/system failure 280 Metastatic bladder cancer 320 Lung cancer 458

30. CT with and without contrast

31. 4 views Abdominal X-rays

32. All imaging reviewed by Core lab

33. Patients with elevated Cr had non contrast CT with ultrasound duplex or MRA

35. The Endurant US Regulatory Study Imaging: Size Changes Size Changes ≥ 5mm considered significant 1 Month 6 Months 53mm 37mm

36. The Endurant US Regulatory Study Imaging: Size Changes

38. No Migration

39. No post-op Ruptures

40. No Conversion to Open Repair

41. Limb Compromise from external compression:

42. 2 Additional Limb Occlusions

46. ENGAGE Interim Analysis Acute Procedural Data for first 839 Patients Enrolled Baseline Characteristics AAA Size > 50mm 88.2% Proximal Neck Length 27.8 mm + 13.4 Length < 15 mm 18.1% Procedural Data Deployment Success 99.6% Implant Duration 90 min (20-300) General Anesthesia 63.3% Length of Stay 5 days (0.5 – 217) * As of 05 October 2010